MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X40CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55140
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Confusion/ Disorientation (2553)
Date of Event	07/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a leak occurred.A 106x40cm ekosonic endovascular device was selected for use in a leg case with an antegrade approach.While administering therapy in the intensive care unit (icu), the nurse called the ekos helpline for information regarding transportation of the patient while on ekos to the computerized tomography (ct) scanner.The patient had become more confused over the course of the nurse's shift, and the physician ordered a ct scan to rule out potential issues in the patient's brain.Later on, the ekos helpline was called back, and it was reported that the ekos catheter was at 48 hours of usage and was now leaking at the blue piece that attaches the manifold to the catheter.The catheter was pulled per the physician's orders.The ct scan came back negative for any bleed.The patient was recovering well, and pressure was applied to the stick site post removal of the catheter.
Additional Manufacturer Narrative
Media review: the device was not returned for analysis; however, a video was provided that shows the device leaking from the strain relief of the manifold.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X40CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20043486
• Report Number: 2124215-2024-51886
• Device Sequence Number: 7971368
• Product Code: KRA
• UDI-Device Identifier: 00858593006172
• UDI-Public: 00858593006172
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2025
• Device Model Number: 500-55140
• Device Catalogue Number: 500-55140
• Device Lot Number: 8035253061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2024
• Initial Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown